CTRI/2016/01/006527
Completed
Phase 4
Pharmacokinetics-Pharmacodynamics relationship of vancomycin in children with suspected or proven Gram-positive bacterial infection admitted to Pediatric intensive care unit of tertiary care hospital
Seth GSMC and KEM Hospital0 sites12 target enrollmentTBD
Overview
- Phase
- Phase 4
- Intervention
- Not specified
- Conditions
- Health Condition 1: null- Patients admitted to PICU with suspected or proven bacterial infection
- Sponsor
- Seth GSMC and KEM Hospital
- Enrollment
- 12
- Status
- Completed
- Last Updated
- 4 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\.Voluntarily given written, signed, informed consent from legally acceptable representative and assent from patientâ??s aged \>\= 7 to 12 years before performing any screening procedures.
- •2\.Either gender of aged 3 \- 12 years and weight of \>\= 8 kg
- •3\.Patients with suspected or proven Gram â?? positive bacterial infection
- •4\.Patient receiving vancomycin therapy for at least 2 days
Exclusion Criteria
- •1\.Patients with hypersensitivity to vancomycin hydrochloride or any excipients of its formulation or other drugs
- •2\.Participation in any investigational study within 30 days prior to screening.
- •3\.Patients whose Creatinine clearance \<50ml/min
Outcomes
Primary Outcomes
Not specified
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